Part 2: Concentration of Soluble Cytokines in Serum
PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma · Source last updated 2025-03-18
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEDIAN
Unit
Picogram per milliliter
Interval / dispersion
Full Range
Time frame
Cycle 0 (0, 2, 4 and 8 hours post dose on Day 1, 24 hours post dose on Day 2); Cycle 1 (0, 2, 4 and 8 hours post dose on Day 1, 24 hours post dose on Day 2, 72 hours post dose on Day 3)
What was measured
The concentration of Interleukin-2, Interleukin-6, Interferon-gamma and tumor necrosis factor-alpha were measured in this outcome measure.
Analysis population: The PD/Biomarker analysis set included all enrolled participants with at least 1 of the PD/Biomarkers evaluated at pre- and/or post-dose. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.
Groups in this outcome
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
15
Reported measurements
Interleukin-2: Cycle 0; 0 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.10
Not reported
2.1
2.1
Not reported
Interleukin-2: Cycle 0; 2 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.10
Not reported
2.1
27.5
Not reported
Interleukin-2: Cycle 0; 4 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.10
Not reported
2.1
48.6
Not reported
Interleukin-2: Cycle 0; 8 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.10
Not reported
2.1
10.6
Not reported
Interleukin-2: Cycle 0; 24 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
12
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.10
Not reported
2.1
30.1
Not reported
Interleukin-2: Cycle 1; 0 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
14
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.10
Not reported
2.1
2.1
Not reported
Interleukin-2: Cycle 1; 2 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
14
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.10
Not reported
2.1
2.1
Not reported
Interleukin-2: Cycle 1; 4 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
14
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.10
Not reported
2.1
2.1
Not reported
Interleukin-2: Cycle 1; 8 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.10
Not reported
2.1
3.0
Not reported
Interleukin-2: Cycle 1; 24 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.10
Not reported
2.1
2.1
Not reported
Interleukin-2: Cycle 1; 72 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.10
Not reported
2.1
2.1
Not reported
Interleukin-6: Cycle 0; 0 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.00
Not reported
2.0
63.1
Not reported
Interleukin-6: Cycle 0; 2 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.00
Not reported
2.0
7.0
Not reported
Interleukin-6: Cycle 0; 4 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.00
Not reported
2.0
23.1
Not reported
Interleukin-6: Cycle 0; 8 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.00
Not reported
2.0
9.3
Not reported
Interleukin-6: Cycle 0; 24 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
12
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
10.30
Not reported
2.0
2480.3
Not reported
Interleukin-6: Cycle 1; 0 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
14
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
5.05
Not reported
2.0
156.0
Not reported
Interleukin-6: Cycle 1; 2 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
14
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.00
Not reported
2.0
88.6
Not reported
Interleukin-6: Cycle 1; 4 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
14
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.30
Not reported
2.0
78.9
Not reported
Interleukin-6: Cycle 1; 8 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.00
Not reported
2.0
53.3
Not reported
Interleukin-6: Cycle 1; 24 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
3.70
Not reported
2.0
466.7
Not reported
Interleukin-6: Cycle 1; 72 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
7.50
Not reported
2.0
1231.3
Not reported
Interferon-gamma: Cycle 0; 0 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
4.20
Not reported
4.2
4.2
Not reported
Interferon-gamma: Cycle 0; 2 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
4.20
Not reported
4.2
4.2
Not reported
Interferon-gamma: Cycle 0; 4 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
4.20
Not reported
4.2
4.2
Not reported
Interferon-gamma: Cycle 0; 8 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
4.20
Not reported
3.0
4.2
Not reported
Interferon-gamma: Cycle 0; 24 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
12
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
4.20
Not reported
4.2
47.3
Not reported
Interferon-gamma: Cycle 1; 0 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
14
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
4.20
Not reported
4.2
4.2
Not reported
Interferon-gamma: Cycle 1; 2 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
14
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
4.20
Not reported
4.2
4.2
Not reported
Interferon-gamma: Cycle 1; 4 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
14
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
4.20
Not reported
2.2
4.2
Not reported
Interferon-gamma: Cycle 1; 8 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
4.20
Not reported
4.2
4.2
Not reported
Interferon-gamma: Cycle 1; 24 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
4.20
Not reported
4.2
7.5
Not reported
Interferon-gamma: Cycle 1; 72 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
4.20
Not reported
4.2
4.2
Not reported
Tumor necrosis factor-alpha: Cycle 0; 0 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
1.70
Not reported
1.7
2.8
Not reported
Tumor necrosis factor-alpha: Cycle 0; 2 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
1.70
Not reported
1.7
58.5
Not reported
Tumor necrosis factor-alpha: Cycle 0; 4 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
1.70
Not reported
1.7
20.8
Not reported
Tumor necrosis factor-alpha: Cycle 0; 8 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
1.70
Not reported
1.7
3.9
Not reported
Tumor necrosis factor-alpha: Cycle 0; 24 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
12
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
2.55
Not reported
1.7
12.7
Not reported
Tumor necrosis factor-alpha: Cycle 1; 0 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
14
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
1.70
Not reported
1.7
4.9
Not reported
Tumor necrosis factor-alpha: Cycle 1; 2 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
14
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
1.70
Not reported
1.7
5.2
Not reported
Tumor necrosis factor-alpha: Cycle 1; 4 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
14
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
1.70
Not reported
1.7
5.8
Not reported
Tumor necrosis factor-alpha: Cycle 1; 8 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
1.70
Not reported
1.7
3.6
Not reported
Tumor necrosis factor-alpha: Cycle 1; 24 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
1.70
Not reported
1.7
5.2
Not reported
Tumor necrosis factor-alpha: Cycle 1; 72 hours
Analysis denominator · Participants
Group
Source count
Part 2A: PF-06863135 SC
13
Values in Picogram per milliliter · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2A: PF-06863135 SC
1.70
Not reported
1.7
2.9
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
lower Limit
2.1
upper Limit
2.1
value
2.10
denoms
counts
group Id
OG000
value
13
units
Participants
title
Interleukin-2: Cycle 0; 0 hours
categories
measurements
group Id
OG000
lower Limit
2.1
upper Limit
27.5
value
2.10
denoms
counts
group Id
OG000
value
13
units
Participants
title
Interleukin-2: Cycle 0; 2 hours
categories
measurements
group Id
OG000
lower Limit
2.1
upper Limit
48.6
value
2.10
denoms
counts
group Id
OG000
value
13
units
Participants
title
Interleukin-2: Cycle 0; 4 hours
categories
measurements
group Id
OG000
lower Limit
2.1
upper Limit
10.6
value
2.10
denoms
counts
group Id
OG000
value
13
units
Participants
title
Interleukin-2: Cycle 0; 8 hours
categories
measurements
group Id
OG000
lower Limit
2.1
upper Limit
30.1
value
2.10
denoms
counts
group Id
OG000
value
12
units
Participants
title
Interleukin-2: Cycle 0; 24 hours
categories
measurements
group Id
OG000
lower Limit
2.1
upper Limit
2.1
value
2.10
denoms
counts
group Id
OG000
value
14
units
Participants
title
Interleukin-2: Cycle 1; 0 hours
categories
measurements
group Id
OG000
lower Limit
2.1
upper Limit
2.1
value
2.10
denoms
counts
group Id
OG000
value
14
units
Participants
title
Interleukin-2: Cycle 1; 2 hours
categories
measurements
group Id
OG000
lower Limit
2.1
upper Limit
2.1
value
2.10
denoms
counts
group Id
OG000
value
14
units
Participants
title
Interleukin-2: Cycle 1; 4 hours
categories
measurements
group Id
OG000
lower Limit
2.1
upper Limit
3.0
value
2.10
denoms
counts
group Id
OG000
value
13
units
Participants
title
Interleukin-2: Cycle 1; 8 hours
categories
measurements
group Id
OG000
lower Limit
2.1
upper Limit
2.1
value
2.10
denoms
counts
group Id
OG000
value
13
units
Participants
title
Interleukin-2: Cycle 1; 24 hours
categories
measurements
group Id
OG000
lower Limit
2.1
upper Limit
2.1
value
2.10
denoms
counts
group Id
OG000
value
13
units
Participants
title
Interleukin-2: Cycle 1; 72 hours
categories
measurements
group Id
OG000
lower Limit
2.0
upper Limit
63.1
value
2.00
denoms
counts
group Id
OG000
value
13
units
Participants
title
Interleukin-6: Cycle 0; 0 hours
denoms
counts
group Id
OG000
value
15
units
Participants
description
The concentration of Interleukin-2, Interleukin-6, Interferon-gamma and tumor necrosis factor-alpha were measured in this outcome measure.
dispersion Type
Full Range
groups
description
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
id
OG000
title
Part 2A: PF-06863135 SC
param Type
MEDIAN
population Description
The PD/Biomarker analysis set included all enrolled participants with at least 1 of the PD/Biomarkers evaluated at pre- and/or post-dose. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.
reporting Status
POSTED
time Frame
Cycle 0 (0, 2, 4 and 8 hours post dose on Day 1, 24 hours post dose on Day 2); Cycle 1 (0, 2, 4 and 8 hours post dose on Day 1, 24 hours post dose on Day 2, 72 hours post dose on Day 3)
title
Part 2: Concentration of Soluble Cytokines in Serum
Triangle